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DIODE LASER

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PI LOT™ LAS ER SA F E T Y G U IDE

C LIN IC AL LAS ER S AF ET Y GU IDE
for use with the

Pilot™ Class IV Surgery/ erapy Diode Laser CAO GROUP™
COMPREHENSIVE LASER SAFETY pg. 2 LASER SAFETY STANDARD pg. 3 EQUIPMENT STANDARDS AND DOCUMENTATION pg. 4 THE LASER SAFETY OFFICER pg. 5 LASER CLASSIFICATIONS pg. 6 WARNINGS AND SAFETY NOTICES pg. 7 LASER SAFETY CHECKLIST pg. 8
For more information, check us out online at: www.pilotlaser.com e-mail us at: vet@caogroup.com call us at (877) 877-9778 or (801) 256-9282, ext. #5505 4628 W. Skyhawk Drive West Jordan, UT 84084 wwww.caogroup.com 877-877-9778 toll free 801-256-9282 phone 801-256-9287 fax

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P I LOT™ LAS ER SA F E T Y G U IDE
COMPREHENSIVE LASER SAFETY
The CAO Group recommends implementation of a comprehensive Laser Safety Program appropriate for usage and location. The program should include the following: • Delegation of authority and responsibility for supervision and control of the laser to a designated (LSO) Laser Safety Officer. • Minimum Training requirements for laser users • Appropriate security to prevent unauthorized use of the laser • Standard operating procedures to regulate the work environment in order to protect the patient and office staff from laser hazards For more information on the contents of a Laser Safety Plan you can review the ANSI Standard Z136.3 for Safe User of Laser in Health Care Facilities or TR IEC 60825-8 Continuing Education The Laser Safety Officer should insure that the operator and staff attend laser courses taught by qualified laser educators. Ongoing reviews of laser safety procedures should be a part of normal office routine. Higher power surgical and therapeutic lasers for use in veterinary clinics are becoming more common as a primary device rather than an adjunctive methodology or treatment. Although high power lasers have significant advantage for cutting and penetration in deep musculoskeletal tissues, the potential risk for injury is greater with high power lasers because of the greater energy density per unit area as compared to low power class III lasers. Class IIIb lasers are those ranging from 5-500mw. Class IV laser have power ratings over 500mw in continuous wave or energy density of 10 J/cm2 in pulsed modulation. (1) In musculoskeletal therapy and surgical applications, however, the class IV laser power ranges from 500mw to 12,000mw. As with all procedures of this type, some element of risk is present through negligence or accident. For example, additional musculoskeletal injury or exacerbation may occur from premature or excessive application of therapeutic exercise. Burns from hot packs and galvanic stimulation are known to occur. Deep tissue burns and tissue cavitation are possible from ultrasound and diathermy. Frostbite occurs from cryotherapy and excessive spray and stretch technique. Infection hazards are often overlooked from bacterial and fungal cross-contamination occurring with poorly sanitized equipment. These hazards are easily prevented or reduced with safety protocols for each application. Laser therapy is extremely safe when basic protocols are followed by the laser operator and support staff. The primary reason for following laser safety measures is to prevent potential thermal injury to the retina with direct or reflected laser. The lens of the eye effectively magnifies laser beam; therefore, a relatively low wattage laser has the potential of damaging the retina with brief exposure. A laser beam of sufficient power can produce permanent retinal damage when the beam enters the lens and is magnified on the retina surface. With higher power lasers, permanent blindness can be the result. Premise: This document assumes clinician using this information has not had formal training or experience with the use/implementation of medical lasers in a practice setting. Goal: The goal of this document is to provide practical information for safe and effective clinical use of the 9 Watt diode laser. This guideline will help the practitioner and staff understand essential safety and start up issues associated with implementing laser surgery and/or therapy in a practice setting. Safe policies and practices must be established; untrained personnel must remain outside nominal laser hazard zones. You may need to consider how to handle exceptions such as the insistent client who needs to be present during a therapy session if physical restraint may be required during a biostimulation procedure. By law a client is not allowed to be in the nominal laser hazard zone; if an accident occurs the clinician and/or LSO may be liable. Eyewear is required for all staff working in the laser's nominal hazard zone; specific filters are required and should be provided by the manufacturers. This eyewear will be specific to the laser wavelengths (in nanometers) and the optical density (OD) required for use with this equipment. The LSO will include this information in the written standard operating procedures. Sta Training a good example of a typical training module was produced by Vanderbilt University and can be viewed at http://www.safety.vanderbilt.edu/training/flash/laser/player.html. Health screening: All employees working within the laser's nominal hazard zone are required to have preliminary screening and eye examinations. A standard screening exam offered by an optometrist suffices to meet the pre-use screening requirement. The new LSO can get ahead of the game by having personnel get the required exams early in the acquisition process so as to avoid wasted time once the device is in place to then have to wait on staff to get the required pre-screening exams out of the way. While the new LSO is learning about lasers and safety, develop a quick start summary that will allow newly trained staff to quickly refer to the SOP essentials.

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LASER SAFETY STANDARDS
Beam Hazards vs. Non-Beam Hazards Beam and non-beam hazards present with the use of Class IV lasers need to be identified and appropriately dealt with. Beam hazards result from contact to the body with the laser beam itself. Non-beam hazards are secondary effects of the laser beam or of the device used to generate the beam. Common examples of non-beam hazards include: • High voltage electrical hazards: most medical lasers used in a standard veterinary practice will not be associated with this kind of hazard. It would be expected for any laser used in a standard veterinary practice to run from a standard 110 volt outlet. • Ignition: medical lasers can and will ignited fires if used improperly. Flammable materials and pure oxygen environments exist in conjunction with laser use. Under the right conditions these can contribute to significant ignition events that can risk the patient's health as well as the health of the operator and support staff. Isopropyl alcohol, exam/surgical gloves, endotracheal tubes, paper and cloth drapes are all common sources of accidental ignition. • Explosion: flammable gasses can be ignited by lasers under the right conditions. • Plume contaminants: vaporizing body tissues liberates chemicals and in some cases viable biological materials such as viruses, bacteria, tumor cells, etc. which can pose health risks to patients and staff who come into contact with this material. By law, every class 4 laser has an emergency stop button and an operator's key. The new LSO will need to ensure trained and appropriate staff has access to the laser while untrained staff can never operate the laser. Place the key in a lockable area that trained clinical staff can quickly/easily access while they are in the clinic performing work, and then to place the key into the locked area when they are at breaks, at lunch, and when the clinic shuts down, so that non-trained staff cannot operate the laser. One way to do this is to keep the key where Controlled Substance records are kept; typically the access level for this regulated clinical resource will be almost identical to the access level desired for clinical laser use. It is a good idea to make a copy of the laser key as soon you get the laser, as it cannot be operated without the key. Be sure you clearly define the nominal hazard zone relevant to your clinical situation. Most medical laser uses are indoors and are performed in a room dedicated for that laser application. In a veterinary practice the laser may need to be used in a stall, out in a field, in a barn, etc. The LSO needs to calculate the nominal hazard zone based on the minimal permitted exposure values for that laser. A suction device to manage the laser plume created through typical use needs to be implemented for safest use of the laser. Plumes can contain viable infectious material as well as carcinogens. Because of this the plume needs to be managed to reduce the exposure risk for the staff to a minimum. The CAO Group recommends N-95 dust/mist masks are used regularly to avoid inhaling the laser plume. In order to use these masks, any staff wearing them has to be fit-tested. Whether you use these masks or not it is a good idea to review the regulation associated with the use of facial/respiratory protective equipment prior to starting laser use in the hospital. Signage: Specific signage is required to be displayed at eye level when operating various classes of lasers. For Class IV lasers the word DANGER must be used with specific coloring and patterning. In addition, specific instruction regarding protective clothing, nominal hazard zone proximity, etc. must be prominently displayed on warning signs in the laser use area. OSHA Provisions Worker safety is the responsibility of the employer and is regulated by OSHA (Occupational Safety and Health Administration), a division of the U.S. Department of Labor. OSHA has issued no specific standard for safe use of lasers but recognizes ANSI standard Z136.1 as a source for analyzing safety with respect to medical lasers. For more information see OSHA Technical Manual (TED 1-0.15A) Section III, Chapter 6, 1999. CAO Group recommends implementation of a Laser Safety Program for the safety of patients and office staff in connection with the use of the Pilot™ laser. American National Standards Institute (ANSI) - Safety Standards ANSI is a non-governmental, non-profit agency that has established guidelines and safety standards for the use of lasers and other electro-optics. The provisions of ANSI Z 136.3 outline standards for lasers used in medicine and the assessment of laser risks. ANSI establishes guidelines for safety eyewear, and classifies all lasers based on their potential for damage to eyes or tissue. Mandatory Performance Standards All laser devices distributed for both human and animal treatment in the U.S. are subject to Mandatory Performance Standards. They must meet the Federal laser product performance standard and must submit an "initial report" to CDRH's Office of Compliance prior to distributing the product (see 21 CFR 1000-1040.11). This performance standard specifies the safety features and labeling that all laser products must have in order to provide adequate safety to users and patients. Maximum Permissible Exposure (WIPE) MPE is the maximum level of laser radiation to which a person may be exposed without hazardous effects or biological changes in the eye or skin. The MPE is determined by the wavelength of a laser, the energy involved, and the duration of the exposure. MPE is a necessary parameter in determining the appropriate optical density and the nominal hazard zone.

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PI LOT™ LAS ER SA F E T Y G U IDE
EQUIPMENT STANDARDS & DOCUMENTATION
Equipment • Key lock switch can only be done with the proper key. This key cannot be removed except when the laser is in the OFF position. The laser can be operated only when this key is in place and is in the ON position • The laser emission indicator is located on the control panel • In order for the laser to function, the remote interlock jack must be in place so that electrical continuity is made across the contacts • The protective housing of the laser prevents unintended access to laser radiation • The controls are located on the control panel for economically functional access during system operation • The power display is prominently located on the control panel • The safety shutter is fail-safe so that full attenuation of the laser beam is accomplished • If laser emission is interrupted for any reason, a manual re-set will turn off the laser so that it goes into a disable mode • The foot pedal has a protective housing to prevent unintentional laser discharge • The software diagnostics include error detection if specifications fall outside a pre-determined range • The emergency stop switch is located for easy access • The laser automatically reverts to the lowest power setting when the laser is turned from stand-by mode to active mode • There is a separate and distinct enable button • All accessories must be plugged in, in order for the laser to operate (delivery system, foot pedal, key, power cord, remote interlock) • There is a separate and distinct stand-by or disable button • System time-out puts the system in the disable mode if the laser has been in the enable mode but has not been used for a period of 10 minutes • Certain lasers have lockable castors ANSI Standards The ANSI Standard Laser Hazard Classifications are used to signify the level of hazard inherent in a laser system and the extent of safety controls required. These range from Class 1 lasers (which are inherently safe for direct beam viewing under most circumstances) to Class 4 laser (which require the most strict controls). The pertinent parameters are: • Laser output energy or power • Radiation wavelengths • Exposure duration • Cross-sectional area of the laser beam at the point of interest Documentation • Keep records and have them available onsite • Maintain current qualification status on Laser Safety Officer (LSO) qualifications • Know all Standard Operating Procedures (SOP) for laser use • Keep and maintain records of all laser safety Inspections • Maintain Laser Injury Management Protocols (LIMP) in case of accidental injury • Document all incidents or accidents CENTER FOR DEVICES AND RADIOLOGICAL HEALTH About the CDRH The FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, re-label, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions. Contact the CDRH Reporting guides and related regulatory information are available directly from the CDRH Center for Devices and Radiological Health U.S. Food and Drug Administration - CDRH/FDA Consumer Assistance Center 10903 New Hampshire Avenue W066-4521 Center for Devices Silver Spring, MD 20993-0002 and Radiological Health 800-638-2041 (Voice - Toll-free) 301-796-7100 (Voice) Email: dsmica@fda.hhs.gov Website: www.fda.gov/AboutFDA/CentersOffices/CDRH/default.htm

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LASER SAFETY OFFICER
The Laser Safety O cer Laser operators are responsible for providing information and safety protection to untrained personnel who may enter the laser controlled areas as visitors. The laser area should be: • Restricted to authorized personnel only • Designed to allow for rapid emergency egress • Equipped with a device that allows for deactivation of the laser or reduction of the output to below the MPE • Designed to fulfill Class 3b controlled area requirements • Designed with entry safe controls • Designed such that the laser has interlocks designed to turn off the power supply or interrupt the beam by means of shutters. The beam path must be free of specularly reflective surfaces and combustible objects and the beam terminated in a non-combustible, non-reflective barrier or beam stop • Visible above 500 mW radiant power A laser safety officer (LSO) must be appointed before using the Class IV laser in a clinical environment. The safe use of a laser is the responsibility of the Laser Safety Officer (LSO). It is his/her responsibility to train staff, maintain training and laser mechanical performance records, perform safety checks, and prepare the laser for use on a daily basis. Once the LSO has sufficient introductory training, the next step is to create customized written safety procedures for use of the laser. The LSO must also keep records of any incident that relates to the failure of the laser or any adverse effects related to laser use, and report any such incidents as prescribed by law. The LSO assures a medical follow-up has been sought or has occurred following any adverse incident during treatment. The LSO is also responsible for the training of all office personnel who are involved with the laser preparation and use. Daily checks of the facility and equipment are also the LSO’s responsibility. The LSO should test fire the laser each day prior to beginning each treatment procedure. Additional Duties of the Laser Safety O cer (LSO) The Laser Safety Officer: • Directs and is responsible for laser safety practices • Authorized to shut down laser operation if safety protocols are violated • Maintain familiarity with the operator manual and with safety procedures including the adverse effects reporting mechanism • Maintain the instrument and accessories in accordance with the manufacturer's recommendations • Maintain familiarity with the safety recommendations and requirements of standards organizations, (e.g. CDRH, and OSHA) • Ensures that the laser is operated only by trained and authorized personnel • Secures the key to the laser in a safe place • Ensures that personnel wear safety eyewear of the appropriate optical density • Ensures laser safety signs are posted during operation of the laser • Ensures laser maintenance is current • Documents procedures (in the patient chart) • Checks inventories and maintains laser supplies and accessories • Makes sure that staff is current on laser education • Assists with training and evaluation when a new laser system is needed • Makes suggestions to the laser surgical team • Cross-trains other clinic and office personnel • May be the physician or other designated person Laser Safety O cer Training Laser Safety Officer training is available through many resources. Many laser safety courses also include information for the use of industrial and research lasers which may not be applicable to the typical clinical situation. The desired training courses will provide a curriculum specific to the job of establishing and maintaining a safe program for laser use in a hospital setting. These courses are available both on-line and through instructor-led courses. Prices range from $500.00 - $1000.00. Be sure that any safety course you attend provides copies of the relevant standards (ANSI Z 136.1 and Z 136.3) with the price of the training course. A good, motivated RVT makes a great LSO for a practice. Laser Safety Program Development Applicable standards: ANSI Z136.1 and ANSI Z136.3. These standards can be purchased through the ANSI store: http://webstore.ansi.org/?source=cj State and/or local standards may dictate how lasers are used regionally. Consult with your state/local health and safety authority to check for additional regulations and guidelines.

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PI LOT™ LAS ER SA F E T Y G U IDE
LASER CLASSIFICATIONS
Laser Classi cations
Laser classi cations are described below: Class I Exempt Lasers and Laser Systems • All Class I lasers must be labeled • Class 1 laser cannot, under normal operating conditions, produce damaging radiation levels. These lasers are exempt from the requirements of most corporate Laser Safety Programs. Example: A laser printer is an example of a Class I laser Class II Low Power Visible Lasers and Laser Systems • Class II lasers must be labeled • Class II lasers are low power lasers or laser system in the visible range (400 - 700 nm wavelengths) that may be viewed directly under carefully controlled exposure conditions • The laser beam should not be purposefully directed toward the eye of any person. Alignment of the laser optical systems (mirrors, lenses, beam deflectors, etc.) should be performed in such a manner that the primary beam, or specular reflection of the primary beam, does not expose the eye to a level above the MPE for direct irradiation of the eye. The work area should be posted with a warning label or sign cautioning users to avoid staring into the beam or directing the beam toward the eye of individuals. If the MPE is exceeded, design viewing portals and/or display screens to reduce exposure to acceptable levels. Example: A bar code scanner is an example of a Class II laser Class III Medium Power Lasers and Laser Systems Class III lasers are medium power lasers or laser systems that require control measures to prevent viewing of the direct beam. Control measures emphasize preventing exposure of the eye to the primary or specularly reflected beam. Class IIIA denotes lasers or laser systems that normally would not produce a hazard if viewed for only momentary periods with the unaided eye. They may present a hazard if viewed using collecting optics. Class IIIA lasers must be labeled accordingly. The work area should be posted with a warning label or sign cautioning users to avoid staring into the beam or directing the beam toward the eye of individuals. Removable parts of the housing and service access panels should have interlocks to prevent accidental exposure. A permanent beam stop or attenuator may also be used. If the MPE is exceeded, design viewing portals and/or display screens to reduce exposure to acceptable levels. Alignment procedures should be designed to ensure the MPE is not exceeded. Class IIIB Medium Power Lasers and Laser Systems • Visible above 1 mW, but not exceeding 5 mW radiant power Example: A laser pointer is an example of a Class IIIB laser Class IIIB denotes lasers or laser systems that can produce a hazard if viewed directly. This includes intrabeam viewing or specular reflections. Except for the higher power Class IIIB lasers, this class laser will not produce diffuse reflections. Class IIIB lasers and laser systems must be labeled accordingly. These lasers are used in areas where entry by unauthorized individuals can be controlled. If an individual who has not been trained in laser safety must enter the area, the laser operator or supervisor should first instruct the individual as to safety requirements and must provide protective eyewear, if required. If the entire beam is not enclosed or if a limited open beam exists, the laser operator, supervisor or laser safety officer should determine a Nominal Hazard Zone (NHZ). An alarm, warning light or verbal countdown should be used during use or start up of the laser. The controlled area should: • Have limited access to spectators • Have beam stops to terminate potentially dangerous laser beams • Be designed to reduce diffuse and specular reflections • Have eye protection for all personnel • Not have a laser beam at eye level • Have restrictions on windows and doorways to reduce exposure to levels below MPE, and require storage or disabling of the laser when it is not being used • Visible above 5 mW, but not exceeding 500 mW radiant power Class IV High Power Lasers and Laser Systems Class IV Lasers are high power lasers or laser systems that can produce a hazard not only from direct or specular reflections, but also from a diffuse reflection. In addition, such lasers may produce fire and skin hazards. Class IV lasers include all lasers in excess of Class III limitations. In addition to the control measures described for Class IIIB, Class IV lasers should be operated by trained individuals in areas dedicated to their use. Failsafe interlocks should be used to prevent unexpected entry into the controlled area, and access should be limited by the laser operator to persons who have been instructed as to the safety procedures and who are wearing proper laser protection eyewear when the laser is capable of emission.

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WARNING & SAFETY NOTICES

DANGER
LASER RADIATION--AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION 810nm DIODE LASER CLASS IV LASER PRODUCT

• Each treatment area should have a “laser in use” warning sign posted at the entrance to the treatment area. This signage serves to warn people to not enter the treatment area without proper safety eyewear and protective clothing when the laser is in use. WARNING: To avoid the risk of electrical shock, this equipment must only be connected to a supply main with protective earth. Statements Regarding Electromagnetic Compatibility (EMC):
Environmental Protection Disposal Of The Equipment: This is a medical laser device; dispose of this device and all accessory items in accordance with state, local and federal rules on the disposal of laser equipment.

WARNING: • Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual.
• Portable and mobile RF communications equipment can affect the performance of the PILOT™ Laser. • The use of accessories, transducers and cables other than those specified by CAO Group may result in increased emissions or decreased immunity of the PILOT™ Laser. • The PILOT™ Laser should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the PILOT™ Laser should be observed to verify normal operation in the configuration in which it will be used.

CAUTION
DO NOT RETRACT STRIPPED FIBER INTO THE CARTRIDGE

Figure 7.0.2 Label required under FDA laser notice 50

LABELS, SIGNS, WARNINGS AND MANUFACTURER’S INFORMATION
Figure 7.0.3 Laser aperture label
DO NOT ACTIVATE LASER WITH FIBER RETRACTED INTO THE CARTRIDGE

Figure 7.0.1 Label required under FDA laser notice 50

Important for All Laser Safety Programs

One of the important aspects of implementing a successful laser safety program is displaying proper signage. According to ANSI Z136.1 Safe Use of Lasers, laser area warning signs should be posted around Class 2M and 3R laser areas, and are required to be posted around all Class 3B and 4 laser areas. Additionally, when Class 3B and Class 4 lasers are being serviced or receiving maintenance of any kind, laser 'notice' signs are required to be posted. All laser clinicians are required to provide laser warning and laser notice signs that meet ANSI Z136.1 requirements for laser safety.

(International Laser Symbol)

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PI LO T™ LA S E R S A F ETY G U IDE
LASER SAFETY CHECKLIST
Laser Safety Checklist - Check When Completed Post a laser warning sign outside the treatment area when the laser is in use The sign should include the DANGER logo The sign should indicate whether visible or invisible laser radiation is being employed The sign should include a warning to avoid eye or skin exposure to direct or scattered laser radiation The sign should include the class type for the laser in use. Most surgical lasers are Class IV Insure that the treatment area is accessible only to authorized personnel Insure that all treatment area personnel wear the appropriate eye protection when the laser Is in use Never look directly into the laser aperture or fiber-optic tip when power is applied, even when laser safety eyewear is being used Minimize or shield reflective surfaces during laser beam operation Traffic Areas Keep laser components (especially the fiber optic cable) out of the mainstream of traffic in the treatment area Protect the fiber-optic cable from kinking, twisting, or otherwise becoming tangled Keep the optical fiber off the floor to minimize the possibility of damage Test fire the laser before using, to insure the integrity of the delivery system Fire Safety Do not use combustible gases in the treatment area Do not use sponges or gauze pads that have been moistened with alcohol to remove debris from fiber tips Electrical Power Inspect all external power cords and footswitch cables Plug the power source in to the wall socket last during set-up, and unplug the power source from the wall socket first during the dismantle process Foot pedal covering should be in place to prevent the accidental depression of the pedal that may lead to accidental laser exposure Plug the Laser directly into the wall rather than into an extention cord Eye Safety - Beam Hazards The greatest single risk for personnel using lasers is eye injury to the cornea or retina from direct or reflected laser beams. Splash guards and face shields should also be used when needed against blood-borne pathogens. Eye protection should be worn by all all persons in the treatment area, including surgeon, staff, and Protective eyewear with the proper optical density for the particular wavelength in use must be clearly labeled. Side shields should be used to protect the eyes from tangential beams and scattered reflections Reflection hazards should be minimized with the use of anodized, blackened or matte retractors and other instruments, especially when using lasers in the visible and near infrared zones of the spectrum. Tissue Protection - Beam Hazards Aim the beam only at target tissue according to recommended treatment protocols Always use the least amount of energy necessary to achieve treatment objectives Protect non-target tissue as recommended Do not use the laser on biological structures for which it was not intended, and for which the laser has not received FDA marketing clearance Ensure there is good visualization of the surgical site before commencing Place the laser in the stand-by mode, disable, or turn the laser off when procedures are completed Airborne Contaminants - Smoke Evacuation for Non-Beam Hazards Use high-volume evacuation during laser surgery to collect and remove the laser plume that may contain bacteria and viral particles, and to minimize objectionable odor of surgery Use high-volume evacuation during laser surgery to draw cooling air across the surgical site Use caution when using an air syringe for cooling, as there is a risk of air emphysema, tissue inflammation, or embolism

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